10.52.12.01. 01 Purpose.. This chapter and COMAR 10.10.13 establish a coordinated Statewide system for:. A. Laboratory screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development; andB. Follow-up services to those infants with abnormal screening results..

10.52.12.02. 02 Scope.. This chapter identifies standards and requirements for the Department, birthing facilities, and persons participating in one or more aspects of Maryland's Newborn Screening Program for hereditary and congenital disorders.

10.52.12.03. 03 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) Birthing Facility.. a) "Birthing facility" means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants.b) "Birthing facility" includes a:. i) Birthing service that is licensed or accredited as a unit of a hospital; and. ii) Freestanding birthing center as defined in COMAR 10.05.02.01B..

10.52.12.04. 04 Responsibilities of the Department.. A. Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.B. Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory o

10.52.12.06. 06 Pre-Test Information.. Before a blood-spot specimen is sent for newborn screening, a health care provider or the individual’s designated representative shall provide to the newborn infant’s parent or guardian an explanation of newborn screening that includes:A. Reasons for newborn screening, including the;. 1) Purpose of the testing; and. 2) Nature and consequences of being affected by a hereditary or congenital disorder or being a carrier of a hereditary or con

10.52.12.07. 07 Initial Screening.. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:A. If the parent or guardian of the newborn infant does not object to newborn screening:. 1) Collect a blood-spot specimen:. a) As set forth in:. i) Sections C and D of this regulation; and. ii) COMAR 10.10.13.13; and. b) Pursuant to the procedures established in COMAR 10.10.13.14A; and.

10.52.12.08. 08 Second Screening.. A health care provider shall have a blood-spot specimen collected for a second screening for the disorders set forth in Regulation .05 of this chapter when the newborn is between 10 and 14 days old.

10.52.12.09. 09 Transport of Blood-Spot Specimens to a Licensed Laboratory.. A. A birthing facility representative, physician, or other health care provider or, in the case when a birth occurs outside a birthing facility, the individual required to prepare and file the certificate of birth, shall send newborn screening blood-spot specimens only to the Department’s public health laboratory for the performance of newborn screening, as set forth in COMAR 10.10.13.14B.B. The individual respons

10.52.12.10. 10 Results.. A. Normal Screening Results.. 1) The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen within 3 business days after receipt of the blood-spot specimen.2) A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:

10.52.12.11. 11 Referral Procedures.. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:A. Develop collection and transport procedures to ensure against collecting and submitting unsatisfactory blood-spot specimens for each of the categories of newborn infant listed in §B of this regulation.B. Collect or otherwise have collected:. 1) An additional blood-spot specimen before the newborn is 7 days old for n

10.52.12.12. 12 Follow-Up Procedures.. A. Department's Responsibilities.. 1) The Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly regarding:a) Results of first-tier, supplemental, and second-tier tests;.

10.52.12.13. 13 Records.. A. The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.B. On request, a laboratory or health care provider shall make available to the Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Follow-Up Unit considers necessary to:1) Screen a newborn infant for hereditary and congenital disorders set forth in Regulation .05 of this chapter;